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"Mutual recognition" and EU food operations

Despite extensive harmonisation efforts in the field of food law, the EU’s “mutual recognition” procedure still has a role to play for food operators, as Katia Merten-Lentz, of international law firm Keller and Heckman, explains.

Mutual recognition was a tool invented many years ago by the European Court of Justice (ECJ) which had to guarantee the free movement of goods where legislation had not been harmonised at EU level. Essentially, it states that where a product is lawfully marketed in one Member State, its’ marketing should be allowed in other Member States.

Today, with the adoption of horizontal food legislation, only very few food products are not covered by harmonised European food law. However, national divergences are still in place as in the case of food supplements. Whilst a positive list of allowed vitamins and minerals is clearly given under Directive 2002/46/CE, other food supplements may be subjected to different national rules.

Next to differences in the conditions of use of a particular food supplement, the Directive explicitly allows national authorities to require “notification” of the placing on the market of food supplements.

Even though a “notification” should not be equal to an authorisation procedure, many Member States place a huge administrative burden on the operators and can require the payment of a fee (Belgium, France, Germany, Slovenia, Finland and Denmark).But the principle cornerstone of mutual recognition requires that all potential hindrances are motivated on their necessity and are proportional to the legitimate objective they serve.

These procedural requirements are elaborated in Regulation 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (in short: the Mutual Recognition Regulation ).The Regulation sets out a procedure which national authorities need to follow before they can restrict goods which are lawfully marketed in another Member State.

Consequently, the marketing of a food supplement cannot be suspended insofar as the concerned Member State has not proven that the restrictive measure is necessary to attain the legitimate objective.

In 2008, a few months after the adoption of the Regulation on mutual recognition, the Commission published a report that optimistically concluded that mutual recognition would be an adequate tool to prevent unnecessary burdens in national food supplements regulations.

In practice however, Member States do not abide by the procedure to the frustration of many producers of food supplement products. Belgian authorities, for example, only allow the marketing of food supplements if they have been granted a notification number. This is a clear infringement to the European procedure under the mutual recognition Regulation.

In 2015, the Commission became aware of these practices and changed its position stating that national regulations and practices continue to create barriers. The Commission recognised in a report (page 18) that “national authorities often require specific proof of lawful marketing or simply refuse access to their national market”, particularly referring to the field of foodstuffs and food supplements. It added that “this increases the costs for economic operators or discourages them from expanding to new markets”.

The latter Communication has resulted in an EU-wide Action Plan to strengthen the application and awareness of mutual recognition. National requirements on food supplements remain in place and hardly any market players eagerly challenge them under the mutual recognition Regulation.

The concept of mutual recognition can be helpful, but is not always effective in removing market barriers. In May 2016, the Mutual Recognition Regulation became the subject of a regulatory evaluation as part of the Action Plan on Mutual Recognition.

The alternative to mutual recognition is harmonisation. Within the ambit of the REFIT evaluation of thenutrition and health claims Regulation, the establishment of a European positive list of permitted plants and plant preparations is being considered.

Such a list would overcome the national notification requirements for at least a great many food supplements. But as long as harmonisation stays out, mutual recognition remains as a valuable alternative and improvements on the application of the principle are desirable.

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